Catalog Number

4166-00

Brand Name

Innomed, Inc.

Version/Model Number

4166-00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KIL

Product Code Name

Positioner, Socket

Public Device Record Key

d48851f5-d13a-42c0-86fe-1bca26b1e090

Public Version Date

October 06, 2022

Public Version Number

1

DI Record Publish Date

September 28, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-